Clinical Trial: Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoart
Brief Summary: The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome:
- WOMAC 3.1 LK questionnaire after 13 weeks of treatment
- Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
Original Primary Outcome:
Current Secondary Outcome:
- Overall OA pain intensity (VAS)by visit
- Physician's global assessment of disease activity (VAS) by visit
- Response to treatment according to OARSI criteria by visit
- Actual OA pain intensity at 12 hours post-dose by visit
- Number of rescue tablets taken during the study
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 7, 2005
Date Started: November 2004
Date Completion:
Last Updated: May 18, 2012
Last Verified: May 2012